Trial Outcomes & Findings for Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy (NCT NCT01085630)

Last Updated: 2021-08-18

Results Overview

Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

Baseline up to 3 years

Results posted on

2021-08-18

Participant Flow

19 enrolled patients were not randomized for the following reasons: progression during first-line therapy, patient refusal, new disease grade 4 brain tumor, patient expired prior to randomization, insufficient creatinine levels, \> 1 week needed to randomize, prolonged adverse events, ineligible due to ECOG performance status being 2 or 3.

Participant milestones

Participant milestones
Measure	Arm A (Observation) Patients undergo observation until disease progression.	Arm B (Pemetrexed) Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Overall Study STARTED	26	27
Overall Study COMPLETED	22	27
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (Observation) Patients undergo observation until disease progression.	Arm B (Pemetrexed) Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Overall Study Insufficient data	1	0
Overall Study Ineligible	3	0

Baseline Characteristics

Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Observation) n=22 Participants Patients undergo observation until disease progression.	Arm B (Pemetrexed) n=27 Participants Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.	Total n=49 Participants Total of all reporting groups
Age, Continuous	68.1 years STANDARD_DEVIATION 10.2 • n=5 Participants	71.0 years STANDARD_DEVIATION 9.0 • n=7 Participants	69.7 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants	27 Participants n=7 Participants	49 Participants n=5 Participants
ECOG Performance Status 0	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
ECOG Performance Status 1	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 3 years

Outcome measures

Outcome measures
Measure	Arm A (Observation) n=22 Participants Patients undergo observation until disease progression.	Arm B (Pemetrexed) n=27 Participants Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Progression-free Survival	3.0 months Interval 2.6 to 11.9	3.4 months Interval 2.8 to 9.8

SECONDARY outcome

Timeframe: Baseline up to 3 years

Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.

Outcome measures

Outcome measures
Measure	Arm A (Observation) n=22 Participants Patients undergo observation until disease progression.	Arm B (Pemetrexed) n=27 Participants Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Overall Survival	11.8 months Interval 9.3 to 28.7	16.3 months Interval 10.5 to 26.0

SECONDARY outcome

Timeframe: Up to 3 years

Population: One patient on the observation arm did not submit any follow-up forms and withdrew consent to all follow-up and thus excluded in this analysis.

The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test

Outcome measures

Outcome measures
Measure	Arm A (Observation) n=21 Participants Patients undergo observation until disease progression.	Arm B (Pemetrexed) n=27 Participants Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Response Rate	0 percentage of participants Interval 0.0 to 0.0	11.1 percentage of participants Interval 2.4 to 29.2

SECONDARY outcome

Timeframe: Baseline up to 3 years

The number of patients reporting grade 3 or higher adverse events considered at least possibly related to study treatment as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.

Outcome measures

Outcome measures
Measure	Arm A (Observation) n=27 Participants Patients undergo observation until disease progression.	Arm B (Pemetrexed) Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) Grade 3 Adverse Event	9 Participants	—
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) Grade 4 Adverse Event	2 Participants	—

Adverse Events

Arm B (Pemetrexed)

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm B (Pemetrexed) n=27 participants at risk Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Blood and lymphatic system disorders Anemia	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Ear and labyrinth disorders Hearing impaired	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Abdominal distension	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Abdominal pain	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Ascites	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Ileus	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Nausea	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
General disorders Fatigue	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Infections and infestations Skin infection	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Infections and infestations Urinary tract infection	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Alanine aminotransferase increased	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Aspartate aminotransferase increased	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Creatinine increased	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations INR increased	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Platelet count decreased	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Hyperglycemia	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Hypoalbuminemia	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Hypocalcemia	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Hypokalemia	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Nervous system disorders Peripheral sensory neuropathy	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Psychiatric disorders Anxiety	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Renal and urinary disorders Proteinuria	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Vascular disorders Thromboembolic event	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.

Other adverse events

Other adverse events
Measure	Arm B (Pemetrexed) n=27 participants at risk Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
Blood and lymphatic system disorders Anemia	66.7% 18/27 • Number of events 101 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Blood and lymphatic system disorders Febrile neutropenia	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Cardiac disorders Atrial fibrillation	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Cardiac disorders Palpitations	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Cardiac disorders Sinus tachycardia	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Ear and labyrinth disorders Hearing impaired	3.7% 1/27 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Ear and labyrinth disorders Vertigo	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Eye disorders Dry eye	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Eye disorders Eyelid function disorder	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Eye disorders Watering eyes	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Abdominal distension	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Abdominal pain	14.8% 4/27 • Number of events 10 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Bloating	3.7% 1/27 • Number of events 16 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Constipation	25.9% 7/27 • Number of events 56 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Diarrhea	14.8% 4/27 • Number of events 14 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Dry mouth	3.7% 1/27 • Number of events 14 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Dyspepsia	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Dysphagia	3.7% 1/27 • Number of events 4 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Hemorrhoids	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Mucositis oral	11.1% 3/27 • Number of events 13 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Nausea	48.1% 13/27 • Number of events 88 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Gastrointestinal disorders Vomiting	18.5% 5/27 • Number of events 9 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
General disorders Chills	3.7% 1/27 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
General disorders Edema limbs	14.8% 4/27 • Number of events 13 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
General disorders Fatigue	81.5% 22/27 • Number of events 170 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
General disorders Fever	7.4% 2/27 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
General disorders Infusion site extravasation	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
General disorders Localized edema	7.4% 2/27 • Number of events 10 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
General disorders Non-cardiac chest pain	14.8% 4/27 • Number of events 23 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
General disorders Pain	22.2% 6/27 • Number of events 10 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Infections and infestations Anorectal infection	3.7% 1/27 • Number of events 6 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Infections and infestations Bronchial infection	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Infections and infestations Eye infection	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Infections and infestations Lung infection	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Infections and infestations Prostate infection	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Infections and infestations Skin infection	7.4% 2/27 • Number of events 14 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Infections and infestations Tooth infection	7.4% 2/27 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Injury, poisoning and procedural complications Fall	3.7% 1/27 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Alanine aminotransferase increased	18.5% 5/27 • Number of events 14 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Alkaline phosphatase increased	11.1% 3/27 • Number of events 10 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Aspartate aminotransferase increased	11.1% 3/27 • Number of events 5 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations CD4 lymphocytes decreased	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Creatinine increased	18.5% 5/27 • Number of events 11 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations GGT increased	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Lymphocyte count decreased	29.6% 8/27 • Number of events 68 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Lymphocyte count increased	3.7% 1/27 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Neutrophil count decreased	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Platelet count decreased	11.1% 3/27 • Number of events 6 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations Weight gain	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Investigations White blood cell decreased	7.4% 2/27 • Number of events 18 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Acidosis	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Anorexia	18.5% 5/27 • Number of events 8 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Dehydration	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Hyperglycemia	29.6% 8/27 • Number of events 72 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Hyperkalemia	7.4% 2/27 • Number of events 9 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Hypernatremia	3.7% 1/27 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Hypoalbuminemia	14.8% 4/27 • Number of events 37 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Hypocalcemia	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Hypomagnesemia	7.4% 2/27 • Number of events 7 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Metabolism and nutrition disorders Hyponatremia	14.8% 4/27 • Number of events 26 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 2/27 • Number of events 6 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Musculoskeletal and connective tissue disorders Arthritis	3.7% 1/27 • Number of events 4 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Musculoskeletal and connective tissue disorders Back pain	14.8% 4/27 • Number of events 8 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Musculoskeletal and connective tissue disorders Chest wall pain	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Musculoskeletal and connective tissue disorders Flank pain	3.7% 1/27 • Number of events 14 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Musculoskeletal and connective tissue disorders Myalgia	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Musculoskeletal and connective tissue disorders Pain in extremity	3.7% 1/27 • Number of events 4 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Nervous system disorders Dizziness	14.8% 4/27 • Number of events 15 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Nervous system disorders Peripheral motor neuropathy	3.7% 1/27 • Number of events 4 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Nervous system disorders Peripheral sensory neuropathy	18.5% 5/27 • Number of events 31 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Psychiatric disorders Anxiety	7.4% 2/27 • Number of events 27 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Psychiatric disorders Insomnia	3.7% 1/27 • Number of events 13 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Renal and urinary disorders Chronic kidney disease	3.7% 1/27 • Number of events 5 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Renal and urinary disorders Proteinuria	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 3/27 • Number of events 5 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 6/27 • Number of events 46 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.7% 1/27 • Number of events 8 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Productive cough	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Wheezing	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Skin and subcutaneous tissue disorders Dry skin	3.7% 1/27 • Number of events 14 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.7% 1/27 • Number of events 19 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Skin and subcutaneous tissue disorders Purpura	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.4% 2/27 • Number of events 5 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	3.7% 1/27 • Number of events 5 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Skin and subcutaneous tissue disorders Urticaria	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Vascular disorders Flushing	3.7% 1/27 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Vascular disorders Hot flashes	3.7% 1/27 • Number of events 21 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Vascular disorders Hypertension	7.4% 2/27 • Number of events 25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Vascular disorders Hypotension	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Vascular disorders Thromboembolic event	7.4% 2/27 • Number of events 5 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
Vascular disorders Vascular disorders - Other, specify	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 3 years. Each CTCAE term is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who received treatment (pemetrexed). Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.

Additional Information

Arkadiusz Z. Dudek M.D., Ph.D.

HealthPartners Cancer Care Center

Phone: 651 254-3321

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place