Autopsy report · NCT01739491
A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia
Cause of deathRegulatory or ethics
“The study is cancelled. FDA Circular 2013-004 mandates that PMSs like this are not required”
Life of this trial
- Withdrawn before it enrolled anyone. Its dates are the sponsor's plans, not events that happened.
Vital statistics
- Status
- Withdrawn
- Sponsor
- Janssen Pharmaceutica
- Sponsor type
- Industry
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- No intervention
- Participants
- 0
Trials that died the same way
- A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain
“The company decided to cancel this study in conformity with PH FDA Circular 2013-004” - A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis
“FDA requested us to stop the study” - Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
“The study stopped due to marketing approval by the FDA.” - Iontophoresis in Psoriasis
“FDA did not provide approval of the use of the drug for the study” - To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Recurrent or Metastatic Breast Cancer
“After meeting with the FDA, SPARC concludes a BE study will not be required”
Look deeper
- The official registry record (the source of truth)
- Record history: every change the sponsor made
- Open it in the database
Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.