Trial · NCT04843007
Alvopem® (Pemetrexed) Safety Assessment
NCT04843007, Completed, NanoAlvand; results first posted 2024-10-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Alvopem® (Pemetrexed) Safety Assessment. Trials, record NCT04843007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04843007
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alvopem® (Pemetrexed) Safety Assessment
- NCT number
- NCT04843007
- Status
- Completed
- Enrollment
- 199 participants, actual
- Lead sponsor
- NanoAlvand
- Conditions
- Non Small Cell Lung Cancer, Malignant Pleural Mesothelioma
- Interventions
- Pemetrexed
- First posted
- 2021-04-13
- Last updated
- 2024-10-23
- Results first posted
- 2024-10-23
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE)) | This outcome was assessed throughout the study, up to 18 weeks (6 chemotherapy cycles). The duration of treatment was at the physicians' discretion based on the patient's condition | In this study, number of participants who experienced at least one adverse event (AE) or one serious adverse event (SAE) were assessed. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and terminology for AEs was chosen according to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term. Also, intensity, seriousness, onset of AEs, and interventions for management of the adverse events were documented in the booklet. For each AE, data was summarized using system organ class and preferred term of AEs and SAEs. Moreover, causality assessment was done based on the World health organization-Uppsala Monitoring Centre (WHO-UMC) system. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE)) | This outcome was assessed throughout the study, up to 18 weeks (6 chemotherapy cycles). The duration of treatment was at the physicians' discretion based on the patient's condition | The safety population is defined as all patients who received at least one dose of the study drug. In this study, a total of 199 patients with non-squamous non-Small cell lung cancer (NSCLC) or malignant pleural mesothelioma (MPM) were enrolled. However, one patient was excluded from the safety analysis due to the absence of a recorded diagnosis, resulting in a safety population of 198 individuals. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE)) | NanoAlvand Pemetrexed | 190 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NanoAlvand Pemetrexed | 199 | |
| Overall Study | COMPLETED | NanoAlvand Pemetrexed | 198 | |
| Overall Study | NOT COMPLETED | NanoAlvand Pemetrexed | 1 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | NanoAlvand Pemetrexed | 177 | 198 | |
| other | leukopenia | Blood and lymphatic system disorders | NanoAlvand Pemetrexed | 49 | 198 | |
| other | neutropenia | Blood and lymphatic system disorders | NanoAlvand Pemetrexed | 57 | 198 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | NanoAlvand Pemetrexed | 20 | 198 | |
| other | Alanine aminotransferase increased | Investigations | NanoAlvand Pemetrexed | 20 | 198 | |
| other | Aspartate aminotransferase increased | Investigations | NanoAlvand Pemetrexed | 12 | 198 | |
| other | Creatinine renal clearance decreased | Investigations | NanoAlvand Pemetrexed | 48 | 198 | |
| other | Renal disorder | Renal and urinary disorders | NanoAlvand Pemetrexed | 1 | 198 | |
| other | Drug intolerance | General disorders | NanoAlvand Pemetrexed | 1 | 198 | |
| serious | Anaemia | Blood and lymphatic system disorders | NanoAlvand Pemetrexed | 50 | 198 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NanoAlvand Pemetrexed | 28 | 198 |
| Total, other adverse events | NanoAlvand Pemetrexed | 190 | 198 |
| Total, serious adverse events | NanoAlvand Pemetrexed | 50 | 198 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36698207 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04843007
GET https://conductscience.org/api/trials/v1/NCT04843007/registered