Trial Outcomes & Findings for A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC (NCT NCT02309892)
NCT ID: NCT02309892
Last Updated: 2024-06-03
Results Overview
Beginning with the start of study treatment at Cycle 1 Day 1 up to the last study visit: An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. Beginning with the AE reporting period at the start of study treatment at Cycle 1 Day 1 up to the last study visit;
TERMINATED
PHASE1
14 participants
Up to 12 weeks
2024-06-03
Participant Flow
Study subjects were enrolled at three study sites in the United States from April 2014 to August 2019.
A total of 14 study subjects diagnosed with metastatic or recurrent non-small cell lung cancer (NSCLC) were enrolled to receive planned escalating doses of L-DOS47 (0.59 - 12.0 ug/kg) in combination with standard doses of carboplatin and pemetrexed.
Participant milestones
| Measure |
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 6.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
1
|
1
|
1
|
2
|
0
|
|
Overall Study
COMPLETED
|
1
|
5
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 6.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC
Baseline characteristics by cohort
| Measure |
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
n=3 Participants
Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
n=6 Participants
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=2 Participants
Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
Total
n=14 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 3.00 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 5.27 • n=7 Participants
|
48 years
STANDARD_DEVIATION 0 • n=5 Participants
|
56 years
STANDARD_DEVIATION 0 • n=4 Participants
|
67 years
STANDARD_DEVIATION 0 • n=21 Participants
|
65.5 years
STANDARD_DEVIATION 10.61 • n=8 Participants
|
—
|
63.5 years
STANDARD_DEVIATION 7.42 • n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
—
|
7 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
—
|
7 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
—
|
11 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
|
ECOG Performance Status
ECOG=0
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
4 Participants
n=24 Participants
|
|
ECOG Performance Status
ECOG=1
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
—
|
10 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Any subject who has received any amount of study treatment.
Beginning with the start of study treatment at Cycle 1 Day 1 up to the last study visit: An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. Beginning with the AE reporting period at the start of study treatment at Cycle 1 Day 1 up to the last study visit;
Outcome measures
| Measure |
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
n=3 Participants
Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
n=6 Participants
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 6.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=2 Participants
Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
|---|---|---|---|---|---|---|---|
|
Number of Patients With Treatment Emergent Adverse Events as a Measure Safety and Tolerability of L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin
Treatment emergent AEs
|
3 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Patients With Treatment Emergent Adverse Events as a Measure Safety and Tolerability of L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin
Treatment emergent AEs related to L-DOS47
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Patients With Treatment Emergent Adverse Events as a Measure Safety and Tolerability of L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin
Treatment emergent SAEs
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Patients With Treatment Emergent Adverse Events as a Measure Safety and Tolerability of L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin
Treatment emergent SAEs related to L-DOS47
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: Any subject who has received all scheduled doses of L-DOS47 in Cycle 1; a DLT is assumed to have occurred if a patient does not receive all scheduled doses of L-DOS47 due to toxicity
A DLT was defined as the occurrence of any of the following events (according to NCI CTCAE version 4.0) that are considered to be (possibly/probably/definitely) related to L-DOS47 and occurring within 21 days after commencing study treatment: * Haematological adverse events ≥ grade 4 * Non-haematological adverse events ≥ grade 3 * One instance each of any two unique grade 2 adverse events
Outcome measures
| Measure |
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
n=3 Participants
Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
n=6 Participants
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 6.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=2 Participants
Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limited Toxicities (DLTs) Related to L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Any subject who experienced a dose-limiting toxicity (DLT); a DLT is also assumed to have occurred if a patient does not receive all scheduled doses of L-DOS47 due to toxicity
Defined as the highest dose level at which ≤ 1 of 6 patients experiences a dose limiting toxicity (DLT) as assessed during the first treatment cycle. If no DLT are reported, it is assumed that the maximum tolerated dose of L-DOS47 in combination with pemetrexed/carboplatin was not reached.
Outcome measures
| Measure |
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
n=3 Participants
Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
n=6 Participants
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 6.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=2 Participants
Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose of L-DOS47 in Combination With Pemetrexed/Carboplatin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Efficacy-evaluable population includes those patients who have completed at least two cycles of study treatment and had at least one post-baseline tumor assessment. For patients with fewer than two cycles of study treatment, there had to be clear evidence of clinical progression. For patients to be evaluable for stable disease, the duration of stable disease must be at least 42 days from the first dose of study treatment.
Objective tumor response will be assessed according to RECIST version 1.1 in patients who have completed at least 2 cycles of study treatment and who have at least 1 post-treatment disease assessment; where complete response (CR) is the disappearance of all target lesions and partial response (PR) is at least a 30% reduction in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
n=6 Participants
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 6.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=2 Participants
Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate of Patients Receiving the Combination Treatment According to RECIST 1.1
Partial response
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Objective Response Rate of Patients Receiving the Combination Treatment According to RECIST 1.1
Stable disease
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Objective Response Rate of Patients Receiving the Combination Treatment According to RECIST 1.1
Progressive disease
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Efficacy-evaluable population includes those patients who have completed at least two cycles of study treatment and had at least one post-baseline tumor assessment. For patients with fewer than two cycles of study treatment, there had to be clear evidence of clinical progression. For patients to be evaluable for stable disease, the duration of stable disease must be at least 42 days from the first dose of study treatment.
Defined as the percentage of patients who have achieved complete response, partial response, or stable disease following combination treatment with L-DOS47 + pemetrexed/carboplatin; where complete response (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% reduction in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and stable disease (SD) is where neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD, at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study).
Outcome measures
| Measure |
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
n=6 Participants
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 Participants
Subjects were to receive a weekly dose 6.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=2 Participants
Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Patients Receiving a Sustained Clinical Benefit
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
Adverse Events
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin
Serious adverse events
| Measure |
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
n=3 participants at risk
Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
n=6 participants at risk
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 participants at risk
Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 participants at risk
Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 participants at risk
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=2 participants at risk
Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Nervous system disorders
loss of consciousness
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Nervous system disorders
syncope
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
33.3%
2/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
1/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Blood and lymphatic system disorders
neutropenia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
1/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
General disorders
chest pain
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Infections and infestations
bacteremia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
1/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Investigations
platelet count decreased
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
1/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
Other adverse events
| Measure |
L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin
n=3 participants at risk
Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin
n=6 participants at risk
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 participants at risk
Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 participants at risk
Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=1 participants at risk
Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin
n=2 participants at risk
Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin
Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed \[500 mg/m2\] and carboplatin \[AUC6\], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
83.3%
5/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
1/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Gastrointestinal disorders
constipation
|
100.0%
3/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
66.7%
4/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Gastrointestinal disorders
abdominal pain
|
66.7%
2/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
General disorders
diarrhea
|
66.7%
2/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Gastrointestinal disorders
gastroesophageal reflux
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Gastrointestinal disorders
hyperchlorhydria
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Gastrointestinal disorders
rectal hemorrhage
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
General disorders
fatigue
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
3/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
General disorders
oedema peripheral
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
66.7%
4/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
General disorders
chest pain
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
3/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
General disorders
pyrexia
|
66.7%
2/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
General disorders
chills
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
General disorders
facial pain
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
General disorders
malaise
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
General disorders
pain
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Metabolism and nutrition disorders
decreased appetite
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
33.3%
2/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Metabolism and nutrition disorders
hypomagnesaemia
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
33.3%
2/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Metabolism and nutrition disorders
weight fluctuation
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
33.3%
2/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Metabolism and nutrition disorders
dyslipidaemia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Metabolism and nutrition disorders
hypoalbuminaemia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Metabolism and nutrition disorders
hypocalcaemia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Metabolism and nutrition disorders
hypokalaemia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Metabolism and nutrition disorders
increased appetite
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Metabolism and nutrition disorders
malnutrition
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
3/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
productive cough
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Blood and lymphatic system disorders
anaemia
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
33.3%
2/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Blood and lymphatic system disorders
neutropenia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
1/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
1/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
rash
|
66.7%
2/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
33.3%
2/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
alopecia
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
dermatitis acneiform
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
hyperdrosis
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
macule
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
rash generalized
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
skin lesion
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Investigations
neutrophil count decreased
|
66.7%
2/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Investigations
white blood cell count decreased
|
66.7%
2/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Investigations
platelet count decreased
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
1/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Investigations
alanine aminotransferase increased
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Investigations
blood creatinine increased
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Investigations
lymphocyte count decreased
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Vascular disorders
hypertension
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
33.3%
2/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Vascular disorders
embolism
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Vascular disorders
flushing
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Vascular disorders
hypotension
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Vascular disorders
pallor
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Vascular disorders
superior vena cava syndrome
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
bone swelling
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Musculoskeletal and connective tissue disorders
pain in jaw
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Nervous system disorders
headache
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
33.3%
2/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Nervous system disorders
neuropathy peripheral
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
33.3%
2/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Nervous system disorders
syncope
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Nervous system disorders
tremor
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Nervous system disorders
dizziness
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Nervous system disorders
loss of consciousness
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Nervous system disorders
polyneuropathy
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Infections and infestations
bacteraemia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
1/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Infections and infestations
oral candidiasis
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Infections and infestations
tooth abscess
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Psychiatric disorders
viral upper respiratory infection
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Psychiatric disorders
insomnia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
50.0%
3/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Psychiatric disorders
anxiety
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
16.7%
1/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Renal and urinary disorders
haematuria
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
33.3%
2/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Cardiac disorders
defect conduction intraventricular
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
|
Cardiac disorders
tachycardia
|
0.00%
0/3 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/6 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
100.0%
1/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/1 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
0.00%
0/2 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
—
0/0 • Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
|
Additional Information
Brenda Lee, Director, Clinical Operations
Helix BioPharma Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place