Trial · NCT02089737
Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)
NCT02089737, Completed, Takeda; results first posted 2017-04-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance). Trials, record NCT02089737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02089737
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)
- NCT number
- NCT02089737
- Status
- Completed
- Enrollment
- 3,091 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Advanced or Recurrent Colorectal Cancer
- Interventions
- Panitumumab
- First posted
- 2014-03-18
- Last updated
- 2017-04-06
- Results first posted
- 2017-04-06
- Limitations and caveats
The present specified drug-use survey is a one-arm observational study with no control group. Therefore, the observed outcome measures provide exploratory information regarding these endpoints; however, do not constitute verification results.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions | Baseline through Week 42 | The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug. |
| Secondary | Progression-free Survival | Up to Week 42 or death (whichever occurred first) | Progression-free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. |
| Secondary | Overall Survival | Up to Week 42 or death (whichever occurred first) | Overall survival was defined as the time to death from the start of panitumumab administration was tabulated. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Drug Reactions | Baseline through Week 42 | Of the 3086 participants who completed the survey form, 3085 participants were included in the safety analysis set after excluding 1 participant for whom information regarding panitumumab treatment and adverse events were missing. | Participants | NUMBER |
| SECONDARY | Progression-free Survival | Up to Week 42 or death (whichever occurred first) | Participants who were included in the efficacy analysis set and received panitumumab monotherapy as a third-line or later therapy. | Months | MEDIAN |
| SECONDARY | Overall Survival | Up to Week 42 or death (whichever occurred first) | All participants that received panitumumab monotherapy as a third-line or later therapy. | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Drug Reactions | Panitumumab | Frequency of adverse drug reactions | 2595 | Participants | |
| Number of Participants With Adverse Drug Reactions | Panitumumab | MedDRA SOC: Skin and subcutaneous tissue disorders | 2364 | Participants | |
| Number of Participants With Adverse Drug Reactions | Panitumumab | MedDRA SOC: Infections and infestations | 771 | Participants | |
| Number of Participants With Adverse Drug Reactions | Panitumumab | MedDRA SOC: Gastrointestinal disorders | 642 | Participants | |
| Number of Participants With Adverse Drug Reactions | Panitumumab | MedDRA SOC: Metabolism and nutrition disorders | 552 | Participants | |
| Number of Participants With Adverse Drug Reactions | Panitumumab | MedDRA SOC: Cardiac disorders | 7 | Participants | |
| Progression-free Survival | Panitumumab | 3.5 | 95% Confidence Interval 3.3 to 4.0 | Months | |
| Overall Survival | Panitumumab | 41 | 95% Confidence Interval 36 to 47 | weeks |
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 | Panitumumab | 3,091 | |
| Overall Study | COMPLETED | Panitumumab | 3,085 | |
| Overall Study | NOT COMPLETED | Panitumumab | 6 |
Source ClinicalTrials.gov
Adverse events434
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 | Paronychia | Infections and infestations | Panitumumab | 269 | 1,254 | |
| other | Paronychia | Infections and infestations | Concomitant Administration of Panitumumab and Chemotherapy | 458 | 1,831 | |
| other | Hypomagnesaemia | Metabolism and nutrition disorders | Panitumumab | 218 | 1,254 | |
| other | Hypomagnesaemia | Metabolism and nutrition disorders | Concomitant Administration of Panitumumab and Chemotherapy | 198 | 1,831 | |
| other | Diarrhoea | Gastrointestinal disorders | Panitumumab | 30 | 1,254 | |
| other | Diarrhoea | Gastrointestinal disorders | Concomitant Administration of Panitumumab and Chemotherapy | 155 | 1,831 | |
| other | Stomatitis | Gastrointestinal disorders | Panitumumab | 123 | 1,254 | |
| other | Stomatitis | Gastrointestinal disorders | Concomitant Administration of Panitumumab and Chemotherapy | 463 | 1,831 | |
| other | Acne | Skin and subcutaneous tissue disorders | Panitumumab | 81 | 1,254 | |
| other | Acne | Skin and subcutaneous tissue disorders | Concomitant Administration of Panitumumab and Chemotherapy | 112 | 1,831 |
1 to 10 of 434Source ClinicalTrials.gov
See all 434 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Panitumumab | ||
| Total, all-cause mortality | Concomitant Administration of Panitumumab and Chemotherapy | ||
| Total, other adverse events | Panitumumab | 640 | 1,254 |
| Total, other adverse events | Concomitant Administration of Panitumumab and Chemotherapy | 1,084 | 1,831 |
| Total, serious adverse events | Panitumumab | 614 | 1,254 |
| Total, serious adverse events | Concomitant Administration of Panitumumab and Chemotherapy | 747 | 1,831 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Panitumumab vs Concomitant Administration of Panitumumab and Chemotherapy: serious adverse events |
Source Trial comparisons
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/NCT02089737
GET https://conductscience.org/api/trials/v1/NCT02089737/events?page=2